To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
548
Treatment applied to affected area twice daily for 7 days
Treatment applied to affected area twice daily for 7 days
Treatment applied to affected area twice daily for 7 days
Investigator Site
Burbank, California, United States
Investigator Site
San Diego, California, United States
Investigator Site
Therapeutic Cure - Superiority Analysis
Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was \<2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
Time frame: 42 days
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Time frame: 42 days
Therapeutic Cure
Subject with clinical and mycological cure at day 7
Time frame: 7 days
Mycologic Cure
Negative KOH and fungal culture at day 42
Time frame: 42 days
Clinical Cure
The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom 1. = Mild - obvious but minimal involvement 2. = Moderate - something that is easily noted 3. = Severe - quite marked Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.
Time frame: 42 days
Safety and Adverse Event Profile
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Miami, Florida, United States
Investigator Site
Martinez, Georgia, United States
Investigator Site
Stockbridge, Georgia, United States
Investigator Site
Clinton Township, Michigan, United States
Investigator Site
Hickory, North Carolina, United States
Investigator Site
Raleigh, North Carolina, United States
Investigator Site
Salisbury, North Carolina, United States
Investigator Site
Sylvania, Ohio, United States
...and 7 more locations
Time frame: 42 days